OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age20-50
SponsorGangnam Severance Hospital

About this trial

Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®).

In these, ovarian function suppression with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ER+HER2- breast cancer

Premenopausal and age <=50

T1 or T2

N1 including micrometastasis

Disqualifiers

Postmenopausal women

ER-negative breast cancer

Trial design

Design model

Single group

Treatments tested in this trial

  • Ovarian function suppression with endocrine treatments

    Drug

    * Ovarian function suppression (OFS) with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years. * Either goserelin acetate or leuprorelin Acetate is allowed. * These patients are able to choose bilateral salpingo-oophorectomy instead of OFS. * Chemotherapy is omitted in these patients.

Treatment groups

418 Participants
are divided into 1 treatment group
Group A: OFS with endocrineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Distant recurrence-free survival

The interval between the date of primary surgery and the date of last censored, or distant recurrence or death of any cause

Time frame
5-years distant recurrence-free survival

Secondary outcomes

1

Recurrence-free survival (RFS)

The interval between the date of primary surgery and the date of last censored, or any type of recurrence or death of any cause

Time frame
5-years RFS
2

Invasive disease-free survival (iDFS)

The interval between the date of primary surgery and the date of last censored, or any type of invasive disease except thyroid cancer or death of any cause

Time frame
5-years iDFS

Other outcomes

Sponsors and contacts

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Gangnam Severance Hospital

Lead sponsor

Seoul National University

Collaborator